PARACETAMOLO 500 mg/30 mg Tablets

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1. PARACETAMOLO E CODEINA DOC Generici 500 mg + 30 mg tablets
   1. What is PARACETAMOLO E CODEINA DOC Generici and what is it used for
   2. What you need to know before taking PARACETAMOLO E CODEINA DOC Generici
2. PARACETAMOLO E CODEINA DOC Generici is contraindicated during breastfeeding
3. PARACETAMOLO E CODEINA DOC Generici may affect the ability to drive vehicles or to
   1. How to take PARACETAMOLO E CODEINA DOC Generici
   2. Possible side effects
   3. How to store PARACETAMOLO E CODEINA DOC Generici
   4. Package Contents and Other Information

PARACETAMOLO E CODEINA DOC Generici 500 mg + 30 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What PARACETAMOLO E CODEINA DOC Generici is and what it is used for
• 2. What you need to know before you take PARACETAMOLO E CODEINA DOC Generici
• 3. How to take PARACETAMOLO E CODEINA DOC Generici
• 4. Possible side effects
• 5. How to store PARACETAMOLO E CODEINA DOC Generici
• 6. Contents of the pack and other information

1. What is PARACETAMOLO E CODEINA DOC Generici and what is it used for

PARACETAMOLO E CODEINA DOC Generici contains two active ingredients (paracetamol and codeine).

• Paracetamol works by relieving pain (analgesic) and reducing fever (antipyretic);
• Codeine belongs to a group of drugs called opioid analgesics that relieve pain.

PARACETAMOLO E CODEINA DOC Generici is indicated in patientsover 12 years of agefor
the treatment of symptoms of moderate acute pain, which does not respond to treatment with other pain-relieving medicines
such as paracetamol or ibuprofen used alone.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking PARACETAMOLO E CODEINA DOC Generici

Do not take PARACETAMOLO E CODEINA DOC Generici

• if you are allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol), to codeine or to any of the other ingredients of this medicine (listed in section 6);
• if you are under 12 years of age;
• if you suffer from a lung disease (respiratory failure), as codeine may worsen your condition;
• if you are between 0 and 18 years old and have undergone removal of tonsils or adenoids because you suffered from a breathing disorder called obstructive sleep apnea syndrome;
• if you have a liver enzyme that allows your body to convert codeine into a high amount of morphine (detected through urine testing) with a high probability of having serious side effects;
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Consult your doctor or pharmacist before taking PARACETAMOLO E CODEINA DOC Generici.
Consult your doctor if:

• you suffer from mild/moderate reduced liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance that causes a yellowish coloring of the skin and eyes);
• you suffer from severe liver problems;
• you suffer from acute hepatitis (acute inflammation of the liver);
• you are taking medicines that stimulate liver enzymes (increasing the way the liver works);
• you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause hemolytic anemia);
• you suffer from hemolytic anemia (a disease due to the destruction of some blood cells, red blood cells);
• you suffer from kidney failure (kidney diseases);
• you abuse alcohol chronically or consume it excessively (3 or more alcoholic beverages per day);
• you suffer from anorexia (an eating disorder characterized by a lack or reduction of appetite);
• you suffer from bulimia (an eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it to avoid gaining weight);
• you suffer from cachexia (a condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases);
• you suffer from chronic malnutrition;
• you suffer from dehydration (severe loss of water/fluids from the body);
• you suffer from hypovolemia (reduced blood volume circulating in the body);
• you have a cough and produce phlegm.

During treatment with PARACETAMOLO E CODEINA DOC Generici, immediately inform
your doctor if:

• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). Patients in these situations have reported a serious condition called metabolic acidosis (an abnormality of the blood and fluids) when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid, deep breathing, drowsiness, nausea and vomiting.

Paracetamol may cause serious skin reactions that can be fatal. The use of
PARACETAMOLO E CODEINA DOC Generici must be stopped at the first appearance of a rash
or any other sign of hypersensitivity (allergic reaction).
Opioid therapy can cause:

• respiratory depression (reduction of respiratory function) and sedation, lowering of the convulsive threshold (i.e. increased excitability of the nervous system, as in the case of epilepsy);
• hyperalgesia (increased sensitivity to pain);
• constipation (difficult or infrequent bowel movements);
• nausea and vomiting;
• masking of the symptoms of acute abdominal conditions (conditions characterized by severe pain and signs of irritation of the abdomen);
• obstruction of the outflow of bile and pancreatic juice, as in the case of some diseases of the biliary tract, for example pancreatitis (inflammation of the pancreas) and cholelithiasis (presence of gallstones in the gallbladder);
• increased release of histamine, as in the case of asthma (bronchial obstruction);
• itching;
• reduction of hormone levels;
• inhibition of immunological function (i.e. the function of the body's defense system);
• muscle rigidity and myoclonus (rapid involuntary muscle twitch);
• urinary retention (difficulty emptying the bladder) particularly in patients with narrowing of the urethra (the last tract of the urinary tract) or with enlargement of the prostate.

Use of high doses and/or taking it for prolonged periods:
The use of high or prolonged doses of paracetamol can cause a liver disease (hepatopathy) and
alterations also serious to the kidney and blood.
Prolonged use of analgesics, including opioids, increases the risk of headache (headache) from drug abuse.
In addition, in elderly people, prolonged use may worsen a pre-existing condition.
With prolonged use of opioids, a reduction in analgesic efficacy (tolerance) may occur. Prolonged
administration of codeine or at doses higher than therapeutic ones can lead to physical and psychological
dependence (habituation) and withdrawal syndrome following sudden discontinuation of
administration, which can be observed in both patients and newborns born to codeine-dependent
mothers. PARACETAMOLO E CODEINA DOC Generici should be used with caution in patients
with dependence or with a history of opioid dependence, and alternative analgesic therapies should be considered.

Elderly
Elderly patients may be at greater risk of side effects associated with the use of
opioids, such as respiratory depression and constipation.

Children and adolescents
Donot give codeine to relieve pain in children and adolescents after removal of tonsils
or adenoids for obstructive sleep apnea syndrome.
Children and adolescents should be carefully monitored for signs of central nervous system depression associated with codeine, such as extreme drowsiness and respiratory depression.
Codeine is not recommended for children and adolescents with respiratory problems, as the symptoms
of morphine toxicity may be worse.

Other medicines and PARACETAMOLO E CODEINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
In particular, tell your doctor if you are taking:

• other medicines containing paracetamol, as if paracetamol is taken in high doses, serious side effects may occur;
• other medicines containing opioidsor other substances that depress the central nervoussystem, to avoid the risk of overdose or serious side effects;
• coumarin anticoagulants including warfarin(medicines that delay blood clotting): the doctor will carry out more rigorous monitoring of INR values (time taken for the blood to clot);
• medicines or substances that stimulate liver enzymes (increasing the way the liver works),for example:
• rifampicin (an antibiotic)
• cimetidine (a medicine used in the treatment of stomach ulcers)
• antiepileptics (medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine and phenytoin. If treated with phenytoin, do not take high or prolonged doses of paracetamol.
• The use of these medicines with PARACETAMOLO E CODEINA DOC Generici requires extreme caution and must be carried out only under strict medical control.
• probenecid, a medicine used to treat hyperuricemia (high concentration of uric acid in the blood) and gout (inflammation of the joints due to uric acid deposition): the doctor will advise you to reduce the doses of PARACETAMOLO E CODEINA DOC Generici;
• salicylamide(a pain reliever and fever reducer);
• flucloxacillin(an antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that needs urgent treatment (see paragraph 2);
• chloramphenicol(an antibiotic): may increase the risk of possible side effects;
• medicines that slow down gastric emptying, such as anticholinergics: these medicines delay the effect of PARACETAMOLO E CODEINA DOC Generici;
• zidovudine(a medicine for the treatment of HIV);
• potent painkillers(buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine);
• naltrexone(a medicine to treat drug dependence);
• antihistamines(medicines to treat allergies);
• analgesics(alfentanil, destromoramide, destropropoxyphene, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol);
• medicines to treat cough(dextromethorphan, noscapine, pholcodine, codeine, etymorphine);
• medicines to treat psychiatric disorders(chlorpromazine, haloperidol, levomepromazine, thioridazine);
• methadone(a medicine to treat drug dependence);
• meprobamate(a medicine to treat anxiety);
• benzodiazepines and barbiturates(medicines to treat insomnia and anxiety);
• medicines to treat depression(paroxetine, fluoxetine, bupropion, sertraline, imipramine, clomipramine, amitriptyline, nortriptyline, doxepin, mirtazapine, mianserin, trimipramine and monoamine oxidase inhibitors);
• antihypertensives(medicines to treat high blood pressure);
• baclofen,a medicine to reduce and relieve muscle spasms (excessive tension in the muscles that occurs in various diseases);
• thalidomide,a medicine to treat multiple myeloma (a disease of the immune system, the body's defense system);
• celecoxib(a medicine that relieves inflammation);
• quinidine(a medicine to treat irregular heartbeat);
• dexamethasone(a medicine to treat various disorders such as inflammation and allergies);
• anticholinergics(medicines to treat various conditions such as bladder problems, allergies and depression).

The concomitant use of PARACETAMOLO E CODEINA DOC Generici and sedatives such as
benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing
(respiratory depression), coma and can endanger the patient's life. For these reasons, concomitant use
should be considered only when alternative treatments are not possible. If your doctor prescribes
PARACETAMOLO E CODEINA DOC Generici together with sedatives, the dose and duration of
concomitant treatment must be established by your doctor. Tell your doctor about all the sedatives you
are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform
friends or relatives to be aware of the onset of the above signs and symptoms. Contact your doctor when
these symptoms occur.

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, be aware that the administration of
paracetamol may interfere with the determination of uricemia (the amount of uric acid in the blood)
and glycemia (the amount of sugar in the blood).

PARACETAMOLO E CODEINA DOC Generici with alcohol
The concomitant use of alcohol and codeine can increase the sedative effect: the consumption of alcohol
during treatment with PARACETAMOLO E CODEINA DOC Generici is not recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
PARACETAMOLO E CODEINA DOC Generici should not be used during pregnancy unless it has been recommended by your doctor.
Paracetamol
Clinical experience with the use of paracetamol during pregnancy is limited. If necessary, paracetamol may be used during pregnancy and only in cases of absolute necessity. It is appropriate to use the lowest possible dose that relieves pain and to take it for the shortest possible time. The doctor will carefully assess the need for treatment, the duration of treatment and the dose to be taken. Contact your doctor if the pain does not decrease or if you need to take the medicine more often.
Codeine
The available data are not sufficient to exclude an association between malformations and codeine use during pregnancy.
Maternal use of codeine at any stage of pregnancy may be associated with scheduled cesarean delivery. Use in the third trimester may be associated with an increased risk of urgent cesarean delivery, postpartum hemorrhage, and the possible onset of opioid withdrawal symptoms in the newborn, including restlessness, excessive crying, tremors, increased muscle tone (hypertonia), increased respiratory rate (tachypnea), fever (pyrexia), vomiting and diarrhea (see also paragraph “Warnings and precautions”).

Breastfeeding

PARACETAMOLO E CODEINA DOC Generici is contraindicated during breastfeeding

with breast milk (see also paragraph “Do not take PARACETAMOLO E CODEINA DOC Generici”).

Driving and operating machinery

PARACETAMOLO E CODEINA DOC Generici may affect the ability to drive vehicles or to

use machinery as it may cause undesirable effects such as drowsiness and cognitive impairment, such as
altered attention.

PARACETAMOLO E CODEINA DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

3. How to take PARACETAMOLO E CODEINA DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
To avoid the risk of overdose, check that other medicines you are taking (with or without a prescription
medical) do not contain paracetamol or codeine.
Accidental taking of an excessive dose of paracetamol can cause serious liver damage and
death (see paragraph If you take more PARACETAMOLO E CODEINA DOC Generici than
you should).

Adults and adolescents from 12 years of age and weighing more than 60 kg
The recommended dose is 1 or 2 tablets, depending on the intensity of the pain, to be taken 1 to 3
times a day at intervals of at least 6 hours.

Adolescents from 12 years of age and weighing less than 60 kg
The dosage must be determined based on weight.
The recommended dosage is 1 tablet per administration, up to a maximum of 4
tablets per day, at intervals of at least 6 hours.

Children under 12 years of age

Do notgive PARACETAMOLO E CODEINA DOC Generici to children under 12 years of age.

Patients with a kidney disease
If you suffer from a severe kidney disease, the interval between two administrations must be at least 8
hours.

Patients with a liver disease
If you suffer from impaired liver function, the dose must be reduced or the interval between two
administrations prolonged.
The maximum dose should not exceed 4 tablets per day in case of:
adult patients weighing less than 50 kg, liver disease, Gilbert's syndrome, chronic alcoholism,
chronic malnutrition or dehydration.

Elderly
The initial dose should be halved compared to the recommended dosage for adults and may be,
subsequently, increased based on tolerability.

Duration of treatment
The medicine should not be taken for more than 3 days in a row. If the pain does not improve after 3
days, consult your doctor.

Method of administration
Oral use.
Swallow the tablet with a glass of water. Do not break or chew.
The score line is not designed to break the tablet.

If you take more PARACETAMOLO E CODEINA DOC Generici than you should
In case of ingestion/accidental taking of an excessive dose of PARACETAMOLO E CODEINA
DOC Generici, immediately inform your doctor or go to the nearest hospital.

Paracetamol
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to
death, especially if:

• you suffer from liver disease,
• you abuse alcohol,
• you suffer from chronic malnutrition
• you are taking medicines or substances that stimulate liver enzymes (increasing the way the liver works). In case of taking very high doses of paracetamol, the symptoms that may occur within the first 24 hours include:
• nausea;
• vomiting;
• anorexia (loss or reduction of appetite);
• pallor;
• malaise;
• diaphoresis (profuse sweating). If 7.5 g or more of paracetamol is ingested in adults and 140 mg per kg of body weight in children, serious liver damage may occur with consequent alteration of some blood test results (AST, ALT, lactic dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness) or death. Symptoms of damage reach their peak after 3-4 days. CodeineThe maximum dose of opioids varies from individual to individual. Taking an excessive dose of codeine or other opioids can primarily lead to:
• respiratory depression ranging from decreased respiratory rate to apnea (cessation of breathing);
• extreme sedation ranging from drowsiness to coma;
• miosis (constriction of the pupils). Other symptoms related to effects on the central nervous system may also occur, including:
• headache;
• vomiting;
• urinary retention (difficulty emptying the bladder);
• reduction of intestinal motility (peristalsis);
• bradycardia (slowing of the heartbeat);
• hypotension (lowering of blood pressure).

Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.

If you forget to take PARACETAMOLO E CODEINA DOC Generici
Do not take/give the adolescent a double dose to make up for the missed dose.

If you stop taking PARACETAMOLO E CODEINA DOC Generici
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects STOPtreatment with this medicine and
contact your doctor immediately:

• skin reactions that may manifest with:
• itching
• urticaria (appearance of wheals on the skin accompanied by itching)
• skin rash
• erythema (redness of the skin)
• erythema multiforme (condition characterized by the appearance of red spots on the skin with a "bull's-eye" appearance associated with itching)
• Stevens-Johnson syndrome (severe skin disease with the appearance of rashes and exfoliations)
• toxic epidermal necrolysis (severe skin disease characterized by redness, blistering lesions with areas of detachment and skin death)
• acute generalized exanthematous pustulosis (eruption of hundreds of superficial pustules spread all over the body)
• allergic reactions that may manifest with:
• laryngeal edema (swelling of the throat)
• angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
• hypotension (lowering of blood pressure)
• anaphylactic shock (severe allergic reaction)
• hypersensitivity
• respiratory depression (reduction of respiratory activity)

The following side effects may also occur with unknown frequency (cannot be
defined based on available data):

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2)
• anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood)
• thrombocytopenia (decrease in the number of platelets in the blood)
• leukopenia/agranulocytosis/neutropenia (reduction in the number of white blood cells in the blood)
• abnormal liver function
• hepatitis (inflammation of the liver)
• biliary colic (severe pain in the upper abdomen)
• dizziness
• drowsiness
• vertigo
• m y o c l o n u s (r apid involuntary muscle twitch)
• paresthesia (tingling)
• syncope (transient loss of consciousness)
• tremor
• sedation
• confusional state
• drug abuse
• drug dependence
• hallucination
• euphoria (excitement)
• dysphoria (depressed mood with irritability and nervousness)
• acute renal failure (reduction of kidney function)
• interstitial nephritis (inflammation of the kidneys)
• hematuria (blood in the urine)
• anuria (cessation or reduction of urine production by the kidney)
• urinary retention (inability of the bladder to empty completely)
• diarrhea
• abdominal pain
• nausea
• vomiting
• constipation
• reactions to the stomach and intestines
• pancreatitis (inflammation of the pancreas)
• dyspnea (difficulty breathing)
• increased liver enzymes
• decrease or increase in INR (value used to express the time it takes for the

b lood to
coagulate)

• rhabdomyolysis (severe muscle damage)
• asthenia (weakness)
• malaise
• miosis (constriction of the pupils)
• edema (swelling due to fluid accumulation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store PARACETAMOLO E CODEINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
This medicine does not require any particular storage conditions.

6. Package Contents and Other Information

What PARACETAMOLO E CODEINA DOC Generici 500 mg + 30 mg Tablets Contains

• The active ingredients are Paracetamol and Codeine Phosphate. Each tablet contains 500 mg of Paracetamol and 30 mg of Codeine Phosphate.
• The other ingredients are: pregelatinized corn starch, stearic acid, povidone, magnesium stearate, sodium croscarmellose.

Description of the appearance of PARACETAMOLO E CODEINA DOC Generici and package contents
White, round tablet with a score line on one side.
Pack of 16 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano - Italy.

Manufacturer
Kern Pharma, S.L. - Venus 72, Polígono Ind. Colón II - 08228 Terrassa (Barcelona) - Spain.